Tyber Medical, LLC, a private labeler Original Equipment Manufacturer (OEM), of Morristown, New Jersey, received 510(k) clearance from the FDA for its TyWedge Opening Osteotomy Wedge System. The item is a titanium plasma sprayed PEEK wedge implant specifically indicated for fusion.
FDA Clears Tyber Medical’s Wedge System
1 min read Premium comments
Secondary
According t the company’s press release, the TyWedge system features the radiolucent properties of PEEK with a titanium plasma spray coating, as well as an optimized tooth profile for initial stability. This is reported to allow for angular corrections in the foot.
The TyWedge System is optimized for bone graft (autograft or allograft) containment, has radiographic markers for intraoperative visualization and instrumentation for precise implant placement. The TyWedge comes in two configurations with a total of 15 footprints, the Evans TyWedge with nine foot prints and the Cotton TyWedge with six foot prints.
“The TyWedge system marries the radiolucency of PEEK-Optima with the osseointegration properties of titanium allowing for direct visualization of the healing process, ” said Selene G. Parekh, M.D., Associate Professor, Department of Orthopedic Surgery, Duke University.
Chris Faresich, TyWedge Team Leader, said, “This FDA clearance is an important milestone for Tyber Medical where a superior wedge design allows for fusion with the use of allograft or autograft for an optimal flat foot opening osteotomy correction.”
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.